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Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is characterized by a tendency for chronic or relapsing immune activation and inflammation within the gastrointestinal tract. With a prevalence of 2 cases per 1,000 people, IBD is increasingly becoming a significant problem in the Western world. The two major forms of IBD are Crohn’s disease and ulcerative colitis.

 

Crohn’s Disease

Crohn’s disease is a condition of chronic inflammation, potentially involving any part of the alimentary tract from mouth to anus. Inflammation in Crohn’s disease often shows a banded pattern along the longitudinal axis of the gut. Crohn’s disease has a yearly incidence of 4 to 10 per 100,000 and the peak age at diagnosis is 15-25 years. Affected persons usually experience the cardinal symptoms of diarrhea (or constipation), abdominal pain and often weight loss. Frequent complications of Crohn’s disease include blockage of the intestine, sores that may affect surrounding tissue (bladder, vagina or skin), fistulas (tunnels) that often necessitate surgery and fissures (small tears in the lining of the mucosal membrane of the anus).

 

Ulcerative Colitis

Ulcerative colitis specifically affects the large intestine or colon and results in characteristic ulcers or open sores. Cardinal symptoms include bloody diarrhea, abdominal pain, fever, obstruction, weight loss and an increased risk of colon cancer. Ulcerative colitis is an intermittent disease, with silent and active periods, and has a yearly incidence of 3 to 15 per 100,000. The peak ages at diagnosis are 15-25 years and 55-65 years. Ulcerative colitis can be associated with various complications outside of the colon, including ulcers in the mouth, inflammation of the iris, arthritis, inflammation of subcutaneous tissue, thrombosis and pulmonary embolism, and anemia.

 

Etiology

The etiology of IBD is not completely understood but it is believed to be an autoimmune disease with a certain genetic preposition. In healthy individuals, tight regulation of the immune system prevents excessive inflammatory responses towards normal intestinal bacteria. In IBD, the normal intestinal flora likely triggers inappropriate and ongoing activation of the mucosal immune system. This aberrant response is probably facilitated by defects in both the barrier function of the intestinal epithelium and in the mucosal immune system.

 

Standard Care

Pharmacological therapy, although generally effective in alleviating the symptoms, is not curative and instead focuses on inducing and maintaining remission. Standard care involves the administration of amino salicylic acid, corticosteroids or newer biological medications. While there is no cure for Crohn’s disease, ulcerative colitis can be cured by surgical resection   of   the colon.  Recently,  injectable   treatments  including  anti-TNF-alpha antibodies and antibody fragments have been developed for the treatment of IBD. These biological drugs offer new options to patients in dire need of new treatment regimens. Despite these recent introductions however, there still is a lack of orally available, safe and well-tolerated products for the treatment of IBD.

 

ActoGeniX’s Solution

ActoGeniX is developing AG011, an orally administered ActoBiotic™ for the local delivery of the immunoregulatory cytokine IL-10 in the intestinal tract. Phase 2 clinical trials are scheduled to start in the course of 2008.